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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES BETTLACH AIM-ARM 125° F/PFNA BLADE ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

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SYNTHES BETTLACH AIM-ARM 125° F/PFNA BLADE ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES Back to Search Results
Catalog Number 03.010.406
Device Problem Failure to Align (2522)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/15/2016
Event Type  malfunction  
Manufacturer Narrative
Device used for treatment, not diagnosis. Additional narrative: device/aim-arm 125° f/pfna blade is not distributed in the united states, but is similar to device marketed in the usa. Device is an instrument and is not implanted/explanted. Device is not expected to be returned for manufacturer review/investigation. The 510k#: unknown. Device history records review was conducted. The report indicates that the: part 03. 010. 406 / 9633962; manufacturing location: (b)(4); manufacturing date: 21st september 2015; lot of (b)(4) pieces was released based on step 0070 of work order (b)(4). Neither deviation nor any ncrs were marked in this document. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
Event Description
Device report from synthes on an event in (b)(6) as follows: it was reported that during surgery on (b)(6) 2016 for femur trochanteric fracture the drill bit interfered with the nail. The surgeon checked the devices before the surgery. The surgery was prolonged about 1 minute. No information about patient condition and outcome available. This complaint involves 3 parts. Concomitant reported parts: 1x protection sleeve (part 356. 818 lot 8083906); 1x buttress compression nut (part 356. 817 lot 8163286). This report is 1 of 1 for (b)(4).
 
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Brand NameAIM-ARM 125° F/PFNA BLADE
Type of DeviceROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
Manufacturer (Section D)
SYNTHES BETTLACH
muracherstrasse 3
bettlach CH254 4
SZ CH2544
Manufacturer (Section G)
SYNTHES BETTLACH
muracherstrasse 3
bettlach CH254 4
SZ CH2544
Manufacturer Contact
mark vornheder
1302 wrights lane east
west chester, PA 19380
6107195000
MDR Report Key6167990
MDR Text Key62378380
Report Number9612488-2016-10503
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeJA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial
Report Date 11/17/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/12/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number03.010.406
Device Lot Number9633962
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/17/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/21/2015
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 12/12/2016 Patient Sequence Number: 1
Treatment
356.817 LOT 8163286,1X BUTTRESS COMPRESSION NUT; 356.818 LOT 8083906, 1X PROTECTION SLEEVE
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